Gen AI for Drug Safety and Pharmacovigilance

Drug safety and pharmacovigilance are critical components of public health, ensuring that medications are used safely and effectively. Pharmacovigilance involves monitoring the effects of drugs after they have been approved for use, aiming to identify and minimize adverse effects and other drug-related problems. Praxigent help companies to make sure they are FDA Compliant and meets the highest standard of FDA and ICH Regulations and utilize latest technology like Gen AI that play pivotal role in transforming predictive analysis on adverse event reporting by improving the speed and accuracy of signal detection, providing real-time risk predictions, and enhancing patient safety through advanced data processing, monitoring, and prediction capabilities.

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White Paper on Advancement on PV

"Harnessing Amazon Bedrock: PRAXIGENT's Custom Llama 3 70B LLM to Transform Pharmacovigilance"

Our Mission

We aim to empower life sciences companies with cutting-edge solutions that streamline pharmacovigilance processes and ensure regulatory compliance. With PRAXIGENT by your side, you can confidently navigate the ever-evolving landscape of drug safety regulations.

What We Offer

PRAXIGENT provides end-to-end pharmacovigilance and compliance solutions designed to adapt to your organization’s specific needs:

Pharmacovigilance Strategy & Management: Comprehensive services that cover the entire pharmacovigilance lifecycle, from safety data management to signal detection and risk mitigation.
Global Regulatory Compliance: Expert guidance on meeting FDA, ICH, and other regional regulatory standards.
Safety Data Analysis & Reporting: Ensure timely and accurate safety reporting with our streamlined data analysis and submission services.
Auditing & Inspections: Be audit-ready with our in-depth compliance audits and inspection readiness services.
Risk Management & Mitigation Plans: We help you identify, evaluate, and mitigate risks effectively to maintain drug safety and compliance.

Top key FDA and ICH pharmacovigilance regulations Praxigent Specialized:

FDA Adverse Event Reporting Regulations (21 CFR Part 314.80

This regulation mandates that drug manufacturers report adverse events and product complaints for approved drugs, ensuring timely collection and analysis of safety data.

ICH E2E Pharmacovigilance Guideline

This guideline provides a comprehensive framework for the collection, management, and reporting of adverse drug reactions, promoting harmonization among regulatory authorities in the U.S., Europe, and Japan.

FDA REMS (Risk Evaluation and Mitigation Strategies)

Under the FDA's REMS program, certain drugs that pose significant risks require manufacturers to implement specific safety measures to ensure that the benefits outweigh the risks.

ICH E2B (Electronic Transmission of Individual Case Safety Reports)

This guideline outlines standards for the electronic submission of individual case safety reports (ICSRs), facilitating efficient data exchange between companies and regulatory authorities.

How Praxigent stand out...

Regulatory Expertise: Our team is comprised of professionals with extensive knowledge of global pharmacovigilance regulations.
Tailored Solutions: We provide customized services that cater to your unique business and product requirements.
Innovative Tools: Our solutions incorporate the latest technologies to optimize efficiency and reduce compliance-related risks.
Unmatched Support: PRAXIGENT delivers 24/7 support to ensure your business is always ready to meet the demands of regulatory authorities.

Partner with PRAXIGENT Today

Stay ahead of the curve in pharmacovigilance and compliance. With PRAXIGENT, you gain a reliable partner that will guide your organization through the intricacies of global regulatory frameworks, ensuring safety, accuracy, and success.

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